Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT00304694
Status:
UNKNOWN
Last Update Posted:
2006-03-20
First Post:
2006-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'lastUpdateSubmitDate': '2006-03-16', 'studyFirstSubmitDate': '2006-03-16', 'studyFirstSubmitQcDate': '2006-03-16', 'lastUpdatePostDateStruct': {'date': '2006-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['NPC', 'Induction chemotherapy', 'Therapeutic response', '18F-FDG PET'], 'conditions': ['Nasopharyngeal Cancer']}, 'descriptionModule': {'briefSummary': '18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.\n\nWe propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.', 'detailedDescription': 'In order to improve locoregional control and to eradicate micrometastases for patients with locally advanced nasopharyngeal carcinoma (NPC), induction chemotherapy followed by concurrent chemoradiotherapy has been the preferred therapeutic approach.Although it would be of great advantage to identify non-responder during or immediately after therapy to formulate an alternative treatment strategy, non-invasive methods for early evaluation of therapeutic response for advanced NPC patients have not been fully evaluated. Decrease of tumor volume in anatomical images and relief of symptoms in clinical follow-up have been used in many conventional approaches to evaluate the effectiveness of therapy. However, an effective therapy could very well have resulted in early subclinical alterations in tumor physiology and biochemistry. These alterations may have occurred long before changes in the tumor mass become apparent. Thus therapeutic effect may not be assessed accurately using the conventional anatomical imaging studies, such as CT and MRI.Recent studies have shown that 18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.We therefore propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed locally advanced NPC patients who are receiving induction chemotherapy for treatment\n\nExclusion Criteria:\n\n* age below 18 year old\n* pregnancy women'}, 'identificationModule': {'nctId': 'NCT00304694', 'briefTitle': 'Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Whole-Body 18F-FDG PET in Evaluating Induction Chemotherapeutic Response for Locally Advanced Nasopharyngeal Cancer Patients and Correlating With Histopathology: a Prospective Study', 'orgStudyIdInfo': {'id': '940601'}}, 'contactsLocationsModule': {'locations': [{'zip': '10012', 'city': 'Taipei', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ruoh-Fang Yen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital'}], 'centralContacts': [{'name': 'Ruoh-Fang Yen, MD, PhD', 'role': 'CONTACT', 'email': 'rfyen@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5581'}], 'overallOfficials': [{'name': 'Ruoh-Fang Yen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}}}}